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March Edition 2023

Gilero – One-Stop Shop for Design, Development, and Contract Manufacturing of Medical Devices and Electromechanical Drug Delivery Systems

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Medical device companies play a vital role in the life science industry by developing new technologies to match unmet medical needs across both established and emerging healthcare markets. The growing prevalence of chronic diseases such as cancer and diabetes is the driving force behind increasing innovation in medical technology, from surgical instruments and orthopedics to diagnostics and medical imaging.

Gilero is one such company offering end-to-end device design, development and contract manufacturing in the medical and pharmaceutical industries. Specializing in the areas of consumable and reusable medical devices, drug delivery, combination products and complex electromechanical systems, Gilero offers a wide range of services to meet your medical or drug delivery device needs. The company continues to grow its manufacturing capabilities and office locations. 2019 growth plans included the opening of a new manufacturing assembly facility in Pittsboro, NC, a design center in Southern California, and an expansion of Medacys – Gilero’s joint venture toolmaking and medical injection molder in Shenzhen, China. The company opened a Chicago-based design center at the end of 2021, and a manufacturing facility in Tijuana, Mexico in early 2022.

Medical Device Design and Engineering Made Simple with Robust Strategies

Strategy & Innovation: The design process for any medical device, drug delivery system, or combination product is complex, posing unique challenges and requirements specific to each device. Gilero routinely works with both startups and established companies to identify the best approach for developing and commercializing a new device. As part of this initial strategy, their engineers will work with you to understand requirements, research existing technologies, understand the patent landscape, and look for similar devices on the market. This stage of the process will not include any brainstorming or design, but will provide an opportunity to understand feasibility of the idea and determine a path forward. The company accelerates medtech innovation by helping the medical and pharmaceutical clients get their devices to market. If you have an idea for a medical or drug delivery device, but are unsure of where to begin, let the experts at Gilero help you get started.

Concept Development: With a proven track record of success in product development, Gilero prides its ability to develop an entire medical device from nothing more than a problem statement or napkin sketch. This starts in the concept development phase, where initial ideas are developed into viable concepts. Concept development begins by conducting a number of brainstorming sessions with their cross-functional engineering teams. Rapid iteration of concepts will happen through a series of brainstorming sessions, concept sketches, early CAD, and technical reviews. Each iteration will further refine the concept(s).

Prototyping: The ability to fabricate rapid prototypes in-house helps advance device design and streamline the development process. Gilero facilities have the equipment and capabilities necessary to build prototypes for medical and drug delivery device components. The company can create prototypes that look like and feel like finished products to help shorten the lead time for design iteration while evaluating the form, fit and function of the device. In-house prototyping also provides insight into manufacturing methods and costs, potentially leading to lower production costs and a smoother transition into finished device manufacturing.

Device Design & Engineering: Medical device design and engineering is Gilero's specialty. They employ a team of experts skilled in design engineering and product development that integrate with other disciplines across the company, such as human factors, quality, and manufacturing. The company focuses solely on the medical device and drug delivery markets, allowing them to provide best-in-class design and development services for medical devices, combination products, and electromechanical medical systems.

Testing: Gilero offers a range of testing services for medical devices and drug delivery systems, from early proof of concept through final verification & validation. Their medical device testing services include test method development and validation along with test protocol development, execution and reporting. Gilero can complete most types of testing in their onsite test labs. Their engineers routinely manage physical, biological, electrical, and software testing.

Plastic Injection Molding: Gilero provides a range of manufacturing services, including plastic injection molding and injection mold tool building. They focus solely on the medical device and drug delivery markets. Their medical injection molding facilities follow strict design protocols and process controls to ensure that all products meet the required specifications. Depending on client needs and product requirements, they can offer manual or fully automated production lines for molding and assembly.

About | Ted Mosler

Ted Mosler is the Founder and Chief Executive Officer of Gilero. An inventor of over 75 issued US patents, Ted has led the successful design and commercialization of multiple products on the market today. These include devices used in drug access and delivery, blood collection, needle safety, minimally invasive surgery, urology and ophthalmology, among others. Ted has been recognized by his peers for his contributions to design, entrepreneurship, and leadership as the recipient of several awards, including: Medical Design Excellence Awards in 2003 and 2014, Medical Device & Diagnostic Industry’s 100 Notable in 2004, Business Leader Media’s Top 50 Catalyst Entrepreneur in 2011, and Business Journal’s 40 Under 40 Leadership Award in 2014. Previous employers include Alaris Medical Systems (now Becton Dickinson) and Bionix where Ted held senior roles in design and product development engineering.

Mr. Mosler holds a BS in Mechanical Engineering from the University of Toledo and an MBA with a concentration in Technology Commercialization from North Carolina State University.

"The work we do at Gilero matters. We’ve created a culture centered on creating things in a way that can help people."

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